FDA.reportPublic FDA data

Wipe Those Hands

Product NDC
78091-251
11-digit product format
780910251
Labeler code
78091
Product ID
78091-251_408dfb29-a51b-70c7-e063-6294a90a949e
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
Mighty Good Solutions, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-15
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Wipe Those Hands
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1038558

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78091-251-02Wipe Those Hands20 in 1 POUCHCLOTH206
78091-251-02Wipe Those Hands4.05 mL in 1 APPLICATORCLOTH4.056
78091-251-03Wipe Those Hands42 in 1 POUCHCLOTH426
78091-251-03Wipe Those Hands4.05 mL in 1 APPLICATORCLOTH4.056
78091-251-04Wipe Those Hands1 in 1 PACKETCLOTH16
78091-251-04Wipe Those Hands10 in 1 POUCHCLOTH106
78091-251-05Wipe Those Hands30 in 1 POUCHCLOTH306
78091-251-05Wipe Those Hands1 in 1 PACKETCLOTH16
78091-251-06Wipe Those Hands40 in 1 POUCHCLOTH406
78091-251-06Wipe Those Hands4.05 mL in 1 PACKETCLOTH4.056

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78091-251WIPE THOSE HANDS (BENZALKONIUM CHLORIDE) CLOTH [MIGHTY GOOD SOLUTIONS, LLC]3Current NDC, 10 package rows20250502_45b217ee-1524-4508-a18f-7db6a30d5169.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN45b217ee-1524-4508-a18f-7db6a30d51696
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD45b217ee-1524-4508-a18f-7db6a30d51696
1038558benzalkonium chloride 0.13 % Topical ClothSY45b217ee-1524-4508-a18f-7db6a30d51696
1038558benzalkonium chloride 0.13 % Topical SwabSY45b217ee-1524-4508-a18f-7db6a30d51696
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY45b217ee-1524-4508-a18f-7db6a30d51696
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY45b217ee-1524-4508-a18f-7db6a30d51696
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY45b217ee-1524-4508-a18f-7db6a30d51696

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
78091-251-027809102510220 APPLICATOR in 1 POUCH (78091-251-02) / 4.05 mL in 1 APPLICATOR20 applicator2025-04-02NoNoCurrent
78091-251-037809102510342 APPLICATOR in 1 POUCH (78091-251-03) / 4.05 mL in 1 APPLICATOR42 applicator2023-07-15NoNoCurrent
78091-251-047809102510410 PACKET in 1 POUCH (78091-251-04) / 1 APPLICATOR in 1 PACKET / 4.05 mL in 1 APPLICATOR10 packet2023-07-15NoNoCurrent
78091-251-057809102510530 PACKET in 1 POUCH (78091-251-05) / 1 APPLICATOR in 1 PACKET / 4.05 mL in 1 APPLICATOR30 packet2023-07-15NoNoCurrent
78091-251-067809102510640 PACKET in 1 POUCH (78091-251-06) / 4.05 mL in 1 PACKET40 packet2023-07-15NoNoCurrent